BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTEC NDL, GRIPPER PLUS

    MDR report key: 21324272 · Received February 6, 2025

    Report

    Report Number
    3012307300-2025-01566
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 2, 2025
    Report Date
    April 22, 2025
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10610586025570
    PMA / PMN Number
    K021999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - EXPIRATION DATE, D4 - PRIMARY UDI NUMBER AND H4 - DEVICE MFG DATE: CORRECTION. H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: THE SAMPLE RETURNED CONSISTS OF ONE (1) INCOMPLETE SET FOR P/N: 21-2764-24. THE RETURNED SAMPLE WAS RECEIVED IN USED CONDITION, IN A PLASTIC BAG. THE RETURNED SAMPLE WAS VISUALLY INSPECTED WITHOUT MAGNIFICATION AT 12¿ TO 16¿ AND NORMAL CONDITIONS OF ILLUMINATION. RETURNED SAMPLE WAS UNABLE TO PERFORM ANY TEST. PER THE PARTIAL RETURNED SAMPLE, IT WAS OBSERVED THAT IT WAS IN USED CONDITION, AND IT WAS NOT ABLE TO PERFORM ANY FUNCTIONAL TEST ON IT, THE COMPLAINT COULD NOT BE REPLICATED OR CONFIRMED. THE FAILURE MODE OF "A0160 - DIFFICULT TO REMOVE" COULD NOT BE CONFIRMED OR REPLICATED. OTHER ANALYSIS CAN´T BE PERFORMED SINCE WHAT WAS RECEIVED WAS A PARTIAL SET. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING REMOVAL OF THE NEEDLE PART OF THE DEVICE DETACHED. THE NEEDLE WAS REMOVED BY PULLING THE THREAD. THERE WAS A POTENTIAL BLOOD CONTAMINATION FOR THE STAFF. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298775 DELTEC NDL, GRIPPER PLUS SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. 4453645 10610586025570

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male